RECRUITING

Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Primary objective: To evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (PSC). Secondary objectives: To evaluate the change in Alkaline Phosphatase (ALP) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care. To evaluate changes in biomarkers of PSC disease during hymecromone treatment, namely: (a) fibrotic effect (FibroScan); (b) inflammatory biomarkers (serum Hyaluronan (HA)); and, (c) T-cell count.

Official Title

A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).

Quick Facts

Study Start:2023-05-10
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05295680

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging study
  2. * If history of endoscopically confirmed inflammatory bowel disease, currently stable based on Mayo Score / Disease Activity Index (DAI) for Ulcerative Colitis Score ≤ 1, normal inflammatory markers (ESR, CRP and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months
  1. * Currently receiving biologic therapies
  2. * Known allergy to hymecromone
  3. * Cholangiocarcinoma
  4. * Pregnancy
  5. * Serious liver disease

Contacts and Locations

Principal Investigator

Aparna Goel, MD
PRINCIPAL_INVESTIGATOR
Stanford University
Leina Alrabadi, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford Clinic
Redwood City, California, 94063
United States
Stanford Clinic
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Aparna Goel

  • Aparna Goel, MD, PRINCIPAL_INVESTIGATOR, Stanford University
  • Leina Alrabadi, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-10
Study Completion Date2025-05

Study Record Updates

Study Start Date2023-05-10
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • Primary Sclerosing Cholangitis